Diabetes and Endocrinology

Keytruda gets a full approval in endometrial cancer; while Xeljanz will miss another PDUFDA date.

FDA staff raised safety concerns ahead of the advisory panel hearing.

A longstanding four times per day testing requirement will cease, and patients using inhaled insulin now qualify for continuous glucose monitoring.

Semaglutide injection is a weekly injection for chronic weight management in adults.

The AstraZeneca drug is the first SGLT2 inhibitor approved for chronic kidney disease regardless of whether the patient has diabetes.

Application to the FDA is based on results from a placebo-controlled trial showing a 15% decrease in body weight among those who are obese or overweight.

AstraZeneca’s leading diabetes medication could be approved to treat chronic kidney disease for patients with and without type 2 diabetes.

Immediately after the FDA said it found elevated levels of the carcinogenic ingredient N-nitrosodimethylamine (NDMA) in certain extended release (ER) metformin products, the first 2 major recalls are underway.

How the first oral GLP-1 oral treatment for type 2 diabetes is unique and how it will be priced compared to other GLP-1 medications.

FDA approved the first and only ready-to-use insulin for IV infusion in hospitals and acute care settings.

FDA granted Fast Track designation to a popular diabetes drug to reduce the risk of cardiovascular death and hospitalization for heart failure in people with chronic heart failure.

FDA fast-tracks biosimiliar insulin products to elevate competition.

FDA approved first interoperable insulin pump, as well as the only FDA-approved drug for patients with a neglected tropical disease.

Mayo Clinic researchers found that beyond overtesting, focus on HbA1C levels can lead to serious harms for patients, especially as more diabetes drugs are needed to keep HbA1C within desired targets.

A large-scale observational study led by Columbia University researchers may offer new approach to studying diverse patient groups.

Study seeks to determine whether significant improvement in glycemic control can be achieved when regular coaching is part of the process.

Novo Nordisk’s new diabetes drug production facility in Clayton, N.C., will ensure production capacity for these drugs in the United States for the decade ahead.

A systemic review highlights studies that improved medication adherence and patient outcomes using strategies that could be effective if employed in real-world healthcare settings.

Unhydrogenated, unsaturated vegetable oils, such as canola oil, can have health advantages when included in as part of a low-glycemic index (GI) diet in people with type 2 diabetes, according to research presented at American Diabetes Association Scientific Sessions in San Francisco, and published in Diabetes Care.

Older adults with diabetes mellitus may be at increased risk for Alzheimer’s disease or vascular dementia following a hypoglycemic event, according to a study published online by JAMA Internal Medicine on June 10th.

Forty-three members of Congress are urging the Centers for Medicare and Medicaid Services (CMS) not to implement a new policy that prohibits independent community pharmacies from providing same-day, home delivery of diabetes testing supplies (DTS) to homebound seniors.

Although the prevalence of diabetes mellitus in hospitalized patients remains unknown, an estimated one-fourth of inpatients experience hyperglycemia.1 Hyperglycemia is linked to poor health outcomes, and there is evidence that intensive glucose control in the hospital reduces mortality, need for dialysis, infections, and length of stay.2 The American Diabetes Association (ADA) publishes clinical practice guidelines annually, which offer clinicians, patients, researchers, and payers current, evidence-based recommendations on all components of diabetes care, general treatment goals, and tools to evaluate the quality of care. The updated guidelines focus on changes in the recommendations for care of the hospitalized diabetes patient.

On March 29, 2013, FDA approved canagliflozin (Invokana, Janssen Pharmaceuticals, Inc.), a once-daily tablet, indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.

In November 2012, FDA approved tofacitinib (Xeljanz, Pfizer) 5 mg tablets for the treatment of adult patients with moderately to severely active rheumatoid arthritis (RA) who have not had an adequate response to methotrexate or are intolerant to methotrexate. Tofacitinib, an oral non-biologic disease-modifying antirheumatic drug (DMARD) can be used as monotherapy or in combination with methotrexate or other non-biologic DMARDs. It is contraindicated for use with biologic DMARDs or with immunosuppressive agents, such as azathioprine and cyclosporine.

FDA’s recent approval of canagliflozin (Invokana, Janssen Pharmaceuticals) for adults with type 2 diabetes (T2DM), represents a new efficacy and unique approach to diabetes treatment, according to industry experts.

FDA’s recent approval of canagliflozin (Invokana, Janssen Pharmaceuticals) tablets to be used with diet and exercise, to improve glycemic control infor adults with type 2 diabetes (T2DM), represents a new efficacy and unique approach to diabetes treatment, according to industry experts.

Obesity has become a highly prevalent chronic condition that is associated with significant morbidity and mortality. Studies have demonstrated that even as little as 5% to 10% of weight loss is associated with an improvement in cardiovascular risk factors and a reduction in the incidence of type 2 diabetes in high-risk patients. Prior to the recent approval of lorcaserin and extended-release phentermine/topiramate, there had been no new pharmacologic agents approved for the treatment of obesity for 13 years. This article reviews the pharmacologic treatment of obesity including past treatment options, lessons learned in recent years, current short- and long-term treatment options, and future direction. Formulary considerations of currently available agents are discussed.

Patients with type 2 diabetes achieved 6% weight loss with liraglutide 3 mg in a phase 3a obesity trial, according to Novo Nordisk.